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CompletedPhase 3NCT01966003
Official study title

Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Study summary

The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCarboplatin and Paclitaxel

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 19, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Amgen
Interventions being studied
Drug: Carboplatin; Drug: Paclitaxel; Drug: ABP 215; Drug: Bevacizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
  • Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
Reasons someone may not be able to joinExclusion criteria
  • Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
  • Central nervous system (CNS) metastases
  • Malignancy other than NSCLC
  • Palliative radiotherapy for bone lesions inside the thorax
  • Prior radiotherapy of bone marrow
  • Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Life expectancy \< 6 months
  • Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
  • Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
  • Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
  • Other inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteBismarck, North Dakota
  • Research SiteFremantle, Western Australia
  • Research SiteVeliko Tarnovo, Veliko Tarnovo
  • Research SiteRousse

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2017. Always confirm current availability with the study team.

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